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Human anti-salivary gland protein I antibody CLlA Kit (IgM)
EUDAMEDClass IVD General (EU MDR)
Ref CK-2486-100MRef CK-2486-050MRef CJZ-K-2486-M
Identity
- Device Name
- Human anti-salivary gland protein I antibody CLlA Kit (IgM) EUDAMED
- Model / Reference
- CK-2486-100M EUDAMEDCK-2486-050M EUDAMEDCJZ-K-2486-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-2486-100M96 EUDAMEDD-CK-2486-050M9Q EUDAMEDD-CJZ-K-2486-MNR EUDAMED
- Basic UDI-DI
- B-CK-2486-100M96 EUDAMEDB-CK-2486-050M9Q EUDAMEDB-CJZ-K-2486-MNR EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMEDW0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Human anti-salivary gland protein I antibody CLlA Kit (IgM) by Guangzhou Kangrun Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-CK-2486-100M96 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 27ab4a26-c4b5-4969-869e-b258b116e578 61 fields · synced Oct 6, 2026
- EUDAMED e90c194a-39a5-4674-bb19-cdc70b7baf8e 61 fields · synced May 17, 2026
- EUDAMED 87252bc5-cf3d-4c81-bebe-682824bfd420 61 fields · synced May 18, 2026